WASHINGTON, June 16-An FDA advisory panel recommended today that BiDil, a new heart failure drug, should be approved for African Americans, with two panel members voting against the racial indication labeling.

The nine-member panel voted unanimously to recommend the approval for BiDil. The vote for labeling indications limited to African-Americans was 7 to 2.

The recommendation stated that BiDil should be used as add-on therapy for treatment of NYHA Class III patients.

Steven Nissen, M.D. of the Cleveland Clinic, the panel chairman, called the vote "precedent setting." If the FDA follows the panel's advice, BiDil will be the first drug approved for use by patients of a particular race.

The drug, which is a combination of isosorbide dinitrate and hyrdralazine, two generic drugs, works by raising the body's level of nitric oxide, which improves endothelial function thus helping the heart to function more efficiently.

In a phase III trial reported last fall, the drug was tested in 1,050 African-Americans. In that study it demonstrated significant improvements in survival and a reduction in re-hospitalization rates for treatment of congestive heart failure.

A report prepared by FDA staff, which was released earlier this week, also recommended that the drug be approved for use in African-Americans.

But the suggestion that a drug be approved for a specific race is abhorrent to many physicians and is also criticized for a lack of scientific basis. For example, some cardiologists suggest that the reason the drug works in African-Americans may not be a matter of skin color but rather be related to the root cause of their heart failure, which in African Americans is usually hypertension.

By contrast, these critics say, whites who develop heart failure often develop the heart failure as the result of ischemic damage caused by a myocardial infarction or atherosclerosis.

So rather than race, the critics argue, the indication for the drug should be heart failure secondary to hypertension.